StrokeGUTSTROKENCT02008604
Influence of Stroke on the Composition of Intestinal Microbiota
An observational study of Stroke and Transient Ischemic Attack (TIA), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack (TIA)
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital
Who may be able to join
- age: 18 and older
- ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity
- patient consent or consent by a legal representative
- NIHSS > or =9 (stroke patients)
- NIHSS < 1 (for TIA patients)
Who cannot join
- intracranial hemorrhage
- preexisting dysphagia
- signs of infection upon admission (clinical/paraclinical)
- existing antibiotic therapy upon admission or within the last 2 weeks before admission
- mechanical ventilation upon admission
- participation in an interventional therapy study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)
The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- Keywords
- ischemia, stroke, transient ischemic attack (TIA), microbiome, microbiota, gut
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described | |
| TIA patients | patients with a transient ischemic attack (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
composition of intestinal microbiome
The composition of the intestinal metagenome / microbiome will be determined by analyzing the 16S rRNA by 454 Pyrosequencing.
Measured: change between day 1, day 4, day 7, day 14 after stroke
Secondary outcomes (1)
test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)
Analysis of correlation between changes in microbiome (most changed group of bacteria, e.g. lactobacilli) with changes in immunological parameters (e.g. HLA-DR, IL-6, IL-10, CD4-lymphocytes from blood samples).
Measured: days 1, 4, 7 after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany, Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany, PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany, NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008604
- Sponsor's protocol ID
- GUTSTROKE
- Acronym
- GUTSTROKE
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2013
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)
- ClinicalTrials.gov ID
- NCT02008604
- Acronym / sponsor ID
- GUTSTROKE / GUTSTROKE
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- Keywords
- ischemia, stroke, transient ischemic attack (TIA), microbiome, microbiota, gut
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany, Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany, PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany, NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | – |
| TIA patients | – | –patients with a transient ischemic attack (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital
Key inclusion criteria (5 listed)
- age: 18 and older
- ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity
- patient consent or consent by a legal representative
- NIHSS > or =9 (stroke patients)
- NIHSS < 1 (for TIA patients)
Key exclusion criteria (6 listed)
- intracranial hemorrhage
- preexisting dysphagia
- signs of infection upon admission (clinical/paraclinical)
- existing antibiotic therapy upon admission or within the last 2 weeks before admission
- mechanical ventilation upon admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composition of intestinal microbiome
Time frame: change between day 1, day 4, day 7, day 14 after stroke
The composition of the intestinal metagenome / microbiome will be determined by analyzing the 16S rRNA by 454 Pyrosequencing.
1 secondary outcome
test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)
Time frame: days 1, 4, 7 after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack (TIA), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composition of intestinal microbiome (time frame: change between day 1, day 4, day 7, day 14 after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.